Unresectable Locally Advanced or Metastatic MelanomaPhase 1/2NCT07280832
Phase I/II Clinical Study of JMT108 Injection for the Treatment of Advanced Malignant Melanoma and Urinary Tract Tumors
A Phase 1/2 study testing JMT108 in people with Unresectable Locally Advanced or Metastatic Melanoma and Unresectable Locally Advanced or Metastatic Urinary Tract Tumors, run by Shanghai JMT-Bio Inc. at 1 site in China.
Trial summary
This is an open-label, multicenter Phase I/II clinical study conducted in participants with unresectable locally advanced or metastatic melanoma and urinary tract tumors, aiming to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of JMT108 Injection in this population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Locally Advanced or Metastatic Melanoma, Unresectable Locally Advanced or Metastatic Urinary Tract Tumors
- What is being tested?
- JMT108
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 17 Dec 2025to 30 May 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥18 years old.
- Histologically or cytologically confirmed unresectable locally advanced or metastatic melanoma and urinary tract tumors.
- Participants with unresectable locally advanced or metastatic melanoma or urinary tract tumors who have failed prior standard treatment or have no available standard treatment will be enrolled in Phase I; those who have received or not received prior standard treatment will be enrolled in Phase IIa and Phase IIb.
- According to the response evaluation criteria for solid tumors (RECIST 1.1), having at least one measurable lesion.
- ECOG PS of 0-1.
- Expected survival ≥ 3 months.
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- Participants with adequate organ functions.
- Female and male patients of childbearing age agree to take adequate contraceptive measures during and upon completion of the study for 6 months after the last dose. Female participants of childbearing age must have a negative blood pregnancy test within 7 days before the first dose or randomization.
- Voluntarily agree to participate in the study and sign the informed consent.
Who cannot join
- Within 4 weeks prior to the first administration of the investigational drug, the patient had received chemotherapy, radiotherapy, biologic therapy, endocrine therapy, targeted therapy (excluding small-molecule targeted drugs), immunotherapy, or other unmarketed investigational drugs or treatments; for small-molecule targeted drugs, use was within 2 weeks prior to the first administration of the investigational drug or within 5 half-lives of the drug (whichever is longer, not exceeding 4 weeks); and antitumor-indicated traditional Chinese medicine/products were used within 2 weeks prior to the first administration of the investigational drug.
- Prior use of IL-2/IL-15 cytokine therapy.
- Received major organ surgery (excluding needle biopsy) or experienced severe trauma within 4 weeks prior to the first administration of the study drug, or requires elective surgery during the study period.
- Received systemic glucocorticoids or other immunosuppressive therapy within 14 days prior to the first use of the study drug. Exceptions include the following situations: receiving physiological replacement doses of hydrocortisone or other equivalent doses of hormonal therapy (i.e., prednisone ≤ 10 mg/day or other equivalent doses of hormones); receiving topical, ophthalmic, intra-articular, intranasal, and inhaled glucocorticoid therapy; receiving short-course glucocorticoids for preventive treatment (e.g., prevention of contrast agent allergy).
- Known active central nervous system (CNS) metastases and/or leptomeningeal metastases. Patients with stable brain metastases who do not require local treatment for brain metastases are eligible for inclusion.
- Patients with active infections requiring intravenous anti-infective therapy within 14 days prior to the first administration.
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- Has a history of severe cardiovascular and cerebrovascular diseases.
- Has active or recurrent autoimmune diseases.
- Has a known history of receiving immunotherapy with the occurrence of grade ≥3 immune-related adverse events (irAEs) (excluding immune-related endocrine abnormalities that have been stabilized) or grade ≥2 immune-related myocarditis.
- Has a history of arterial or venous thrombosis within 6 months prior to the first administration.
- Has a history of serous effusions such as ascites or pleural effusion requiring drainage within 14 days prior to the first administration.
- Has a history of other malignant tumors within 5 years prior to the first administration or concurrent other malignant tumors.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
BeiJing Cancer Hospital EC
Beijing, Beijing Municipality
Jun Guo, PhD, 13911233048, Guoj307@126.com
About this study
Official title: Open-Label, Multicenter Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of JMT108 Injection in Participants With Unresectable or Metastatic Melanoma and Urinary Tract Tumors
This is an open-label, multicenter Phase I/II clinical study conducted in participants with unresectable locally advanced or metastatic melanoma and urinary tract tumors, aiming to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of JMT108 Injection in this population. The study consists of Phase I and Phase II (including Phase IIa and Phase IIb), where Phase I is the dose-escalation stage, Phase IIa is the dose-expansion stage, and Phase IIb is the cohort-expansion stage.
- Conditions
- Unresectable Locally Advanced or Metastatic Melanoma, Unresectable Locally Advanced or Metastatic Urinary Tract Tumors
- Being tested
- JMT108
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JMT108Drug
Intravenous (IV) administration
| Study group | Role | What they receive |
|---|---|---|
| Phase I: Dose Escalation Stage | Experimental | JMT108 intravenous (IV) administration, use as specified in the clinical study protocol. Receives: Drug: JMT108 |
| Phase IIa: Dose Expansion Stage | Experimental | The administered dose of JMT108 selected by the SMC. Receives: Drug: JMT108 |
| Phase IIb: Cohort 1 | Experimental | RP2D of JMT108 selected by the SMC. Receives: Drug: JMT108 |
| Phase IIb: Cohort 2 | Experimental | RP2D of JMT108 selected by the SMC. Receives: Drug: JMT108 |
| Phase IIb: Cohort 3 | Experimental | RP2D of JMT108 selected by the SMC. Receives: Drug: JMT108 |
| Phase IIb: Cohort 4 | Experimental | RP2D of JMT108 selected by the SMC. Receives: Drug: JMT108 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicity (DLT) (Phase I)
To evaluate the safery of JMT108 in subjects.
Measured: Approximately 28 days.
Adverse Events (AEs) (Phase I)
To evaluate the safery of JMT108 in subjects.
Measured: Through study completion, an average of 1 year
Overall Response Rate (ORR) (Phase II)
Through study completion, an average of 1 year.
Measured: To evaluate the efficacy of JMT108 in subjects.
Secondary outcomes (1)
Maximum plasma concentration (Cmax)
To evaluate the systemic pharmacokinetics of JMT108 in subjects.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start17 Dec 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Locally Advanced or Metastatic MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This is an open-label, multicenter Phase I/II clinical study
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai JMT-Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280832
- Sponsor's protocol ID
- JMT108-003
- Status last verified
- Aug 2026
- First submitted
- 28 Nov 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Multicenter Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of JMT108 Injection in Participants With Unresectable or Metastatic Melanoma and Urinary Tract Tumors
- ClinicalTrials.gov ID
- NCT07280832
- Acronym / sponsor ID
- JMT108-003
- Conditions
- Unresectable Locally Advanced or Metastatic Melanoma, Unresectable Locally Advanced or Metastatic Urinary Tract Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shanghai JMT-Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Dec 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, multicenter Phase I/II clinical study conducted in participants with unresectable locally advanced or metastatic melanoma and urinary tract tumors, aiming to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of JMT108 Injection in this population. The study consists of Phase I and Phase II (including Phase IIa and Phase IIb), where Phase I is the dose-escalation stage, Phase IIa is the dose-expansion stage, and Phase IIb is the cohort-expansion stage.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- This is an open-label, multicenter Phase I/II clinical study
| Arm | Type | Receives |
|---|---|---|
| Phase I: Dose Escalation Stage | Experimental | Drug: JMT108JMT108 intravenous (IV) administration, use as specified in the clinical study protocol. |
| Phase IIa: Dose Expansion Stage | Experimental | Drug: JMT108The administered dose of JMT108 selected by the SMC. |
| Phase IIb: Cohort 1 | Experimental | Drug: JMT108RP2D of JMT108 selected by the SMC. |
| Phase IIb: Cohort 2 | Experimental | Drug: JMT108RP2D of JMT108 selected by the SMC. |
| Phase IIb: Cohort 3 | Experimental | Drug: JMT108RP2D of JMT108 selected by the SMC. |
| Phase IIb: Cohort 4 | Experimental | Drug: JMT108RP2D of JMT108 selected by the SMC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age≥18 years old.
- Histologically or cytologically confirmed unresectable locally advanced or metastatic melanoma and urinary tract tumors.
- Participants with unresectable locally advanced or metastatic melanoma or urinary tract tumors who have failed prior standard treatment or have no available standard treatment will be enrolled in Phase I; those who have received or not received prior standard treatment will be enrolled in Phase IIa and Phase IIb.
- According to the response evaluation criteria for solid tumors (RECIST 1.1), having at least one measurable lesion.
- ECOG PS of 0-1.
Key exclusion criteria (12 listed)
- Within 4 weeks prior to the first administration of the investigational drug, the patient had received chemotherapy, radiotherapy, biologic therapy, endocrine therapy, targeted therapy (excluding small-molecule targeted drugs), immunotherapy, or other unmarketed investigational drugs or treatments; for small-molecule targeted drugs, use was within 2 weeks prior to the first administration of the investigational drug or within 5 half-lives of the drug (whichever is longer, not exceeding 4 weeks); and antitumor-indicated traditional Chinese medicine/products were used within 2 weeks prior to the first administration of the investigational drug.
- Prior use of IL-2/IL-15 cytokine therapy.
- Received major organ surgery (excluding needle biopsy) or experienced severe trauma within 4 weeks prior to the first administration of the study drug, or requires elective surgery during the study period.
- Received systemic glucocorticoids or other immunosuppressive therapy within 14 days prior to the first use of the study drug. Exceptions include the following situations: receiving physiological replacement doses of hydrocortisone or other equivalent doses of hormonal therapy (i.e., prednisone ≤ 10 mg/day or other equivalent doses of hormones); receiving topical, ophthalmic, intra-articular, intranasal, and inhaled glucocorticoid therapy; receiving short-course glucocorticoids for preventive treatment (e.g., prevention of contrast agent allergy).
- Known active central nervous system (CNS) metastases and/or leptomeningeal metastases. Patients with stable brain metastases who do not require local treatment for brain metastases are eligible for inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JMT108Intravenous (IV) administration | Drug | Phase I: Dose Escalation Stage, Phase IIa: Dose Expansion Stage, Phase IIb: Cohort 1, Phase IIb: Cohort 2, Phase IIb: Cohort 3, Phase IIb: Cohort 4 |
Primary outcome
Dose-Limiting Toxicity (DLT) (Phase I)
Time frame: Approximately 28 days.
To evaluate the safery of JMT108 in subjects.
Adverse Events (AEs) (Phase I)
Time frame: Through study completion, an average of 1 year
To evaluate the safery of JMT108 in subjects.
Overall Response Rate (ORR) (Phase II)
Time frame: To evaluate the efficacy of JMT108 in subjects.
Through study completion, an average of 1 year.
1 secondary outcome
Maximum plasma concentration (Cmax)
Time frame: Through study completion, an average of 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing JMT108 in people with Unresectable Locally Advanced or Metastatic Melanoma and Unresectable Locally Advanced or Metastatic Urinary Tract Tumors, run by Shanghai JMT-Bio Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicity (DLT) (Phase I) (time frame: Approximately 28 days.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.